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Data updated: Mar 10, 2026

NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE

NICARDIPINE HYDROCHLORIDE
Cardiovascular Approved 2024-04-17
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-04-17
Routes
INTRAVENOUS
Dosage Forms
INJECTABLE

Companies

INFORLIFE
Active Ingredient: NICARDIPINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE Approval History

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What NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE Treats

2 indications

NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Angina
  • Hypertension
Source: FDA Label

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE FDA Label Details

Pro

Indications & Usage

I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (Se...

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Data Sources

FDA Approval: ANDA203978 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.